Condition category
Infections and Infestations
Date applied
15/04/2005
Date assigned
07/06/2005
Last edited
06/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melba Gomes

ORCID ID

Contact details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A30765

Study information

Scientific title

Acronym

Study hypothesis

Pharmacokinetic studies have shown that pentamidine has a large volume of distribution and elimination occurs over a long period. The objective of the study is to assess the efficacy of 3 days Intramuscular (IM) pentamidine treatment compared to the standard 7 days IM pentamidine treatment regimen.

Ethics approval

Ethics approval received from:
1. World Health Organization (WHO)/Ethics Review Committee (ERC) on the 4th December 2003
2. Instituto de Combate e Control o Das Triponosommiases (ICCT) (Angola) on the 18th October 2004
3. Wandsworth Local Research Ethics Committee (UK) on the 3rd December 2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Human African Trypanosomiasis (HAT)

Intervention

This will be an open, randomised comparison of two pentamidine treatment regimens, given over three days or seven days with a non-inferiority trial design.

Intervention type

Drug

Phase

Not Specified

Drug names

Pentamidine

Primary outcome measures

Proportion of cases with favourable progress at 6 months, based on clinical state and laboratory status.

Secondary outcome measures

1. Proportion of cases with favourable progress at discharge, 3 and 12 months based on clinical state and laboratory status
2. Cure rate at 18 months, based on based on clinical state and laboratory status
3. Frequency and severity of adverse events

Overall trial start date

20/12/2004

Overall trial end date

20/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged more than or equal to 14 years and less than 60 years
2. Parasite positive (on examination of lymph juice, by Capillary Tube Centrifugation [CTC] or miniature Anion-Exchange Centrifugation [mAEC] on whole blood)
3. Alternative diagnoses excluded clinically and by appropriate laboratory investigations
4. Capable of and giving informed consent to the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

The total target was 440 patients, but only 18 were recruited in this site.

Participant exclusion criteria

1. Stage II Human African Trypanosomiasis (HAT): defined as parasites in cerebrospinal fluid (CSF), or having more than or equal to 6 cells/mm^3 in CSF; or more than 100 red cells/mm^3 ("bloody tap")
2. Pregnant
3. Previous HAT
4. Known allergy or reactions to pentamidine
5. Diabetes mellitus
6. Difficulty to comply with follow-up (patients of no fixed abode and refugees, for example)

Recruitment start date

20/12/2004

Recruitment end date

20/12/2006

Locations

Countries of recruitment

Angola

Trial participating centre

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Other

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes